🔍 RecallPedia

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Class I - Dangerous
🏥 Medical Devices Recalled: March 14, 2025 Pro-Med Instruments Gmbh Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model/Item No: 1204.002; UDI-DI: 04250435506738; Serial numbers: 1102010, 1201002, 1201004, 1201005, 1201006, 1201008, 1201009, 1201011, 1206012, 1206013, 1206014, 1206015, 1206016, 1206018, 1310001, 1310002, 1310003, 1312001, 1312002, 1312003, 1312004, 1312005, 1312006, 1312007, 1312008, 1312009, 1312010, 1407011, 1407012, 1407013, 1407014, 1407015, 1407016, 1407017, 1407018, 1407019, 1407020, 1501026, 1501027, 1501028, 1501029, 1501030, 1503031, 1503032, 1503033, 1503034, 1503035, 1503035, 1503036, 1503037, 1503038, 1503039, 1503040, 1505041, 1505042, 1505043, 1505044, 1505045, 1505046, 1505047, 1505048, 1505049, 1505050, 1506051, 1506052, 1506053, 1506054, 1507055, 1509056, 1509057, 1509058, 1509059, 1509060, 1509061, 1509062, 1509063, 1509064, 1509065, 1605066, 1605067, 1605068, 1605069, 1605070, 1605071, 1605072, 1605073, 1605074, 1605075, 1610078, 1610079, 1610080, 1610081, 1610082, 1610083, 1610084, 1610085, 1610086, 1708001, 1708002, 1708003, 1708004, 1708005, 1708006, 1708007, 1708008, 1708009, 1708010, 1801011, 1801012, 1801013, 1802014, 1802015, 1802016, 1802017, 1802018, 1802019, 1802020, 1805021, 1805022, 1805023, 1805024, 1805025, 1806026, 1806027, 1806028, 1806029, 1806030, 1807031, 1807032, 1807033, 1807034, 1811036, 1811037, 1811038, 1811039, 1811040, 1902001, 1902002, 1902003, 1902004, 1902005, 1902006, 1902007, 1902008, 1902009, 1902010, 1910001, 1910002, 1910003, 1910004, 1910005, 1910006, 1910007, 1910008, 1910009, 1910010, 2007001, 2007002, 2007003, 2007004, 2007005, 2007006, 2007007, 2007008, 2007009, 2007010, 2010001, 2010002, 2010003, 2010004, 2012001, 2012002, 2012004, 2012006, 2012007, 2012008, 2012009, 2012010, 2102001, 2104001, 2104002, 2104003, 2104004, 2104005, 2107001, 2107002, 2107006, 2107007, 2112001, 2112002, 2112003, 2202001, 2202002, 2202003, 2202004, 2202005, 2205001, 2205002, 2212001, 2212002, 2212003, 2212004, 2212005, 2301001, 2401001, 2401002, 2401003, 2401004, 2401005, 2401006, 2401007, 2405001, 2405002, 2405003, 2405004, 2408001, 2408002, 2408003, 2409001, 2409002, 2409003, 2409004;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Pro-Med Instruments Gmbh
Reason for Recall:
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Product Codes/Lot Numbers:

Model/Item No: 1204.002; UDI-DI: 04250435506738; Serial numbers: 1102010, 1201002, 1201004, 1201005, 1201006, 1201008, 1201009, 1201011, 1206012, 1206013, 1206014, 1206015, 1206016, 1206018, 1310001, 1310002, 1310003, 1312001, 1312002, 1312003, 1312004, 1312005, 1312006, 1312007, 1312008, 1312009, 1312010, 1407011, 1407012, 1407013, 1407014, 1407015, 1407016, 1407017, 1407018, 1407019, 1407020, 1501026, 1501027, 1501028, 1501029, 1501030, 1503031, 1503032, 1503033, 1503034, 1503035, 1503035, 1503036, 1503037, 1503038, 1503039, 1503040, 1505041, 1505042, 1505043, 1505044, 1505045, 1505046, 1505047, 1505048, 1505049, 1505050, 1506051, 1506052, 1506053, 1506054, 1507055, 1509056, 1509057, 1509058, 1509059, 1509060, 1509061, 1509062, 1509063, 1509064, 1509065, 1605066, 1605067, 1605068, 1605069, 1605070, 1605071, 1605072, 1605073, 1605074, 1605075, 1610078, 1610079, 1610080, 1610081, 1610082, 1610083, 1610084, 1610085, 1610086, 1708001, 1708002, 1708003, 1708004, 1708005, 1708006, 1708007, 1708008, 1708009, 1708010, 1801011, 1801012, 1801013, 1802014, 1802015, 1802016, 1802017, 1802018, 1802019, 1802020, 1805021, 1805022, 1805023, 1805024, 1805025, 1806026, 1806027, 1806028, 1806029, 1806030, 1807031, 1807032, 1807033, 1807034, 1811036, 1811037, 1811038, 1811039, 1811040, 1902001, 1902002, 1902003, 1902004, 1902005, 1902006, 1902007, 1902008, 1902009, 1902010, 1910001, 1910002, 1910003, 1910004, 1910005, 1910006, 1910007, 1910008, 1910009, 1910010, 2007001, 2007002, 2007003, 2007004, 2007005, 2007006, 2007007, 2007008, 2007009, 2007010, 2010001, 2010002, 2010003, 2010004, 2012001, 2012002, 2012004, 2012006, 2012007, 2012008, 2012009, 2012010, 2102001, 2104001, 2104002, 2104003, 2104004, 2104005, 2107001, 2107002, 2107006, 2107007, 2112001, 2112002, 2112003, 2202001, 2202002, 2202003, 2202004, 2202005, 2205001, 2205002, 2212001, 2212002, 2212003, 2212004, 2212005, 2301001, 2401001, 2401002, 2401003, 2401004, 2401005, 2401006, 2401007, 2405001, 2405002, 2405003, 2405004, 2408001, 2408002, 2408003, 2409001, 2409002, 2409003, 2409004;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1860-2025

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